BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 10777590 · Received November 3, 2020

    Report

    Report Number
    1523658-2020-00034
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    April 26, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QLA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. CCDS AND HOSPITAL STAFF HAVE DISCUSSED THE ISSUES REGARDING THE RETURNED MASKS. INFORMATION REQUIRING THE EVALUATION FOR MASK SOILING AND STRAP INTEGRITY WHEN LOADING AND UNLOADING INTO CHAMBERS HAS BEEN DISPERSED TO SITES. NOT ENOUGH INFORMATION TO DETERMINE WHY MASK DIDN'T SEAL. ALL INFORMATION KNOWN OR REASONABLY KNOWN TO BATTELLE HAS BEEN INCLUDED IN THIS SUBMISSION. ANY BLANK FIELDS INDICATE THAT INFORMATION WAS UNAVAILABLE.

    Description of Event or Problem · 1

    USER REPORTED MASK DID NOT SEAL. THE MASKS ASSOCIATED WITH THIS EVENT WERE DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247178 NA RESPIRATOR, DECONTAMINATED QLA BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1